Kelly Services Supplier Quality Engineer in Raynham, Massachusetts
Every day, Kelly Services connects professionals with opportunities to advance their careers.
We currently have a Supplier Quality Engineer III position with one of our clients located in Raynham, MA . Our client is well known as one of the largest, most innovative medical device and solutions, in orthopaedics, spinal care and neuroscience, in the world today.
Supplier Quality Engineer III
The Supplier Quality Engineer III provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of customer products.
Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices GMP, equipment engineering system EES, and international organization for standardization ISO.
Address and correct product and process complaints.
Report on contract manufacturer performance metrics and management reviews.
Oversee audits of all quality system categories to assess compliance to process excellence standards.
Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bound, correct and prevent defects, presenting reports to management.
Will handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship (F1 OPT cannot be considered for this position).
Minimum of a Bachelor s Degree is required . A Degree in Engineering is strongly preferred.
Minimum of 5 years of experience in a GMP and/or ISO regulated industry is required.
Experience in the medical device and/or pharmaceutical industry is preferred.
Operations supplier quality experience is preferred.
Both, FDA and ISO regulations knowledge are required.
FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
Auditing background is preferred.
Strong communication, teamwork, and problem-solving skills are required.
Strong root cause analysis skills are required.
Experience or knowledge with machining manufacturing processes and special process validations e.g. cleaning, passivation is preferred.
Six Sigma, Lean, or ASQ Certification and/or trainings are preferred.
This is a long-term open-ended opportunity, typically multi-year. This opportunity also offers an enhanced benefits package from Kelly Services which includes 401K participation, health insurance, PTO, and paid holidays.
Why Kelly ® ?
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in
industry leading organizations. Top companies throughout the world have trusted Kelly as a premier
source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm
with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety
and flexibility of working on short term project engagements, or prefer contract-to-hire or direct
hire placement with our clients, apply with Kelly to explore opportunities that suit your specific
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.